Healthy Volunteers OnlyNCT06952673
Study on Multi-Modality Models of Cardiac Function in Healthy Individuals
A study testing Multiple speed increments from 3km/h to 8km/h on a treadmill in people with Healthy Volunteers Only, run by Shanghai Ruiwei Digital Technology Co. Ltd. at 1 site in China.
Trial summary
In this study, wearable multi-modal microsensors were deployed to simultaneously capture seismocardiography (SCG) and electrocardiography (ECG) signals, delineating the exercise-load-dependent responsiveness of SCG-ECG dynamic coupling during graded-speed treadmill protocols. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Only
- What is being tested?
- Multiple speed increments from 3km/h to 8km/h on a treadmill
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years
- Healthy individuals with no significant medical history
- Signed informed consent as an acceptance to participate to the trial
Who cannot join
- History of severe cardiovascular, cerebrovascular, pulmonary, hepatic, renal, psychiatric, or other critical systemic disorders
- Peripheral vascular diseases, musculoskeletal disorders, or other conditions limiting physical mobility
- Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg)
- History of anemia
- Moderate to severe obesity (BMI ≥32.5 kg/m²)
- Pregnant or lactating women
- Any other conditions deemed ineligible for participation per investigator's discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Building 16, Lane 775, Hangdong Road, Shanghai
Shanghai, Shanghai Municipality, 201105
SEN WANG, M.D., Ph. D.,, +86 13916165236, 13916165236@163.com
About this study
Official title: Study on the 'Seismocardiography-Electrocardiography' Coupling Dynamics and Its Exercise-load Reactivity Model in Healthy Individuals
In this study, wearable multi-modal microsensors were deployed to simultaneously capture seismocardiography (SCG) and electrocardiography (ECG) signals, delineating the exercise-load-dependent responsiveness of SCG-ECG dynamic coupling during graded-speed treadmill protocols.
Read the detailed description
The heart adapts to varying exercise loads primarily by augmenting heart rate and contractility to achieve matching increases in cardiac output. However, whether there exists an intrinsic triaxial regulatory mechanism governing the interdependencies among 'exercise load - heart rate response - contractility response' remains unknown. In this study, participants performed treadmill exercise at multiple speed gradients (3-8 km/h). Seismocardiography (SCG) signals were captured via an inertial measurement unit (IMU) positioned on the precordium and were used to characterize mechanical cardiac contractility. Single-lead precordial ECG provided heart rate dynamics, while CPET-derived oxygen uptake (VO₂) indexed exercise intensity. The primary objectives were to delineate SCG-ECG responsivity patterns under graded exercise intensities and quantify potential intrinsic laws linking exercise load, heart rate adaptation, and contractility modulation.
- Conditions
- Healthy Volunteers Only
- Being tested
- Multiple speed increments from 3km/h to 8km/h on a treadmill
- Keywords
- Seismocardiography, ECG, Exercise Responsivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple speed increments from 3km/h to 8km/h on a treadmillBehavioural
Healthy participants will undergo a fixed experimental protocol of multi-stage treadmill speed walking/running wearing microsensors and a respiratory/metabolic testing mask.
| Study group | Role | What they receive |
|---|---|---|
| Multiple speed increments on a treadmill for healthy individuals | Experimental | Healthy participants will undergo the following experimental protocol: After wearing microsensors and a respiratory/metabolic testing mask, they will rest quietly for 3 minutes, then begin walking at a speed of 3 km/h for 6 minutes, followed by a 3-minute quiet rest period. This will be followed by walking at 4 km/h for 6 minutes and another 3-minute rest. The protocol continues with subsequent stages at progressively increasing speeds of 5 km/h, 6 km/h, 7 km/h, and 8 km/h, each involving 6 minutes of walking followed by 3 minutes of rest. Receives: Behavioral: Multiple speed increments from 3km/h to 8km/h on a treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Seismocardiography (SCG) Signal Amplitude (m/s²)
Peak-to-peak amplitudes of Seismocardiography (SCG) signals will be measured using a triaxial accelerometer (sampling rate: 500 Hz). The primary parameter assessed is the signal amplitude in meters per second squared (m/s²) per cardiac cycle. Values will be averaged over 30-second artifact-free epochs during rest and exercise stages.
Measured: The entire test will be completed in approximately 90 minutes.
Secondary outcomes (1)
Changes in Electrocardiogram (ECG) R-R Intervals (ms)
R-R intervals, measured in milliseconds (ms), will be derived from a single-lead Electrocardiogram (ECG) recording (sampling rate: 250 Hz). The specific parameter assessed is the time duration between consecutive R-waves. R-peaks will be auto-detected and confirmed by amplitude and slope thresholds. Data will be averaged over 30-second epochs synchronized with SCG signals.
Measured: The entire test will be completed in approximately 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start25 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ruiwei Digital Technology Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952673
- Sponsor's protocol ID
- RW-H-001
- Status last verified
- May 2025
- First submitted
- 19 Apr 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the 'Seismocardiography-Electrocardiography' Coupling Dynamics and Its Exercise-load Reactivity Model in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06952673
- Acronym / sponsor ID
- RW-H-001
- Conditions
- Healthy Volunteers Only
- Keywords
- Seismocardiography, ECG, Exercise Responsivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Shanghai Ruiwei Digital Technology Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, wearable multi-modal microsensors were deployed to simultaneously capture seismocardiography (SCG) and electrocardiography (ECG) signals, delineating the exercise-load-dependent responsiveness of SCG-ECG dynamic coupling during graded-speed treadmill protocols.
Detailed description
The heart adapts to varying exercise loads primarily by augmenting heart rate and contractility to achieve matching increases in cardiac output. However, whether there exists an intrinsic triaxial regulatory mechanism governing the interdependencies among 'exercise load - heart rate response - contractility response' remains unknown. In this study, participants performed treadmill exercise at multiple speed gradients (3-8 km/h). Seismocardiography (SCG) signals were captured via an inertial measurement unit (IMU) positioned on the precordium and were used to characterize mechanical cardiac contractility. Single-lead precordial ECG provided heart rate dynamics, while CPET-derived oxygen uptake (VO₂) indexed exercise intensity. The primary objectives were to delineate SCG-ECG responsivity patterns under graded exercise intensities and quantify potential intrinsic laws linking exercise load, heart rate adaptation, and contractility modulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple speed increments on a treadmill for healthy individuals | Experimental | Behavioral: Multiple speed increments from 3km/h to 8km/h on a treadmillHealthy participants will undergo the following experimental protocol: After wearing microsensors and a respiratory/metabolic testing mask, they will rest quietly for 3 minutes, then begin walking at a speed of 3 km/h for 6 minutes, followed by a 3-minute quiet rest period. This will be followed by walking at 4 km/h for 6 minutes and another 3-minute rest. The protocol continues with subsequent stages at progressively increasing speeds of 5 km/h, 6 km/h, 7 km/h, and 8 km/h, each involving 6 minutes of walking followed by 3 minutes of rest. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years
- Healthy individuals with no significant medical history
- Signed informed consent as an acceptance to participate to the trial
Key exclusion criteria (7 listed)
- History of severe cardiovascular, cerebrovascular, pulmonary, hepatic, renal, psychiatric, or other critical systemic disorders
- Peripheral vascular diseases, musculoskeletal disorders, or other conditions limiting physical mobility
- Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg)
- History of anemia
- Moderate to severe obesity (BMI ≥32.5 kg/m²)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple speed increments from 3km/h to 8km/h on a treadmillHealthy participants will undergo a fixed experimental protocol of multi-stage treadmill speed walking/running wearing microsensors and a respiratory/metabolic testing mask. | Behavioural | Multiple speed increments on a treadmill for healthy individuals |
Primary outcome
Changes in Seismocardiography (SCG) Signal Amplitude (m/s²)
Time frame: The entire test will be completed in approximately 90 minutes.
Peak-to-peak amplitudes of Seismocardiography (SCG) signals will be measured using a triaxial accelerometer (sampling rate: 500 Hz). The primary parameter assessed is the signal amplitude in meters per second squared (m/s²) per cardiac cycle. Values will be averaged over 30-second artifact-free epochs during rest and exercise stages.
1 secondary outcome
Changes in Electrocardiogram (ECG) R-R Intervals (ms)
Time frame: The entire test will be completed in approximately 90 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers Only
Active, not recruiting
TMS With Real-time E-field and EEG Source Imaging
Healthy Volunteers Only
RecruitingPhase 1
A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers
Healthy Volunteers Only
Not yet recruiting
A Study of Body Fat Distribution and Airway Mechanics in Healthy Adults
Healthy Volunteers Only
Not yet recruiting
Effects of Substance P on Headache Induction in Healthy Individuals
Healthy Volunteers Only
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple speed increments from 3km/h to 8km/h on a treadmill in people with Healthy Volunteers Only, run by Shanghai Ruiwei Digital Technology Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEN WANG, M.D., Ph. D., (+86 13916165236, 13916165236@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Seismocardiography (SCG) Signal Amplitude (m/s²) (time frame: The entire test will be completed in approximately 90 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.